Quality & Compliance
Safety & Vigilance
25 april 2023
Clinical studies are a vital aspect of drug development and approval. In a clinical study, the protocol is critical as it is the single-most-important quality control tool for all aspects of a clinical trial. The protocol helps harmonize clinical studies conducted in a multi-center clinical trial where the collaboration of many investigators and their staff at multiple clinical study sites is involved. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial). It ensures the trial subjects’ safety and the data’s integrity.
Each organization has their protocol template/format. This difference in template/format or variability in core content among different sponsors contributes to inefficiencies and difficulties during regulatory submission, especially in searching, reviewing, and assessing clinical trial protocols. Thus, there is a need for a single harmonized protocol template which will help the sponsor or sponsor-investigator in the development of a complete protocol free from ambiguity, well-organized, and aligned with quality by design principles. By conveying information consistently and in the exact location across clinical trial protocols, a protocol template is intended to provide value to parties that include sponsors, investigators, clinical site personnel, trial participants, ethics committees, and regulators.
On 22nd December 2022, USFDA released M11- technical specification- clinical electronic structured harmonized protocol (CESHARP). This guidance aims to create an international standard for the content and exchange of clinical trial protocol information, facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. In addition, the protocol template was released for comments from various stakeholders.
As of February 2023, the document received 23 documents with comments from various pharmaceutical industry groups as well as universities such as Biotechnology Innovation Organization (BIO), LFB Biotechnology, CRISPR Therapeutics, Certara, Coalition for Epidemic Preparedness Innovations (CEPI), Pharmaceutical Research and Manufacturers of America (PhRMA), University of Pennsylvania, etc.
Some of the Critical Findings Expressed by the Community included:
The typical comment from various stakeholders was to use explicit/consistent terminologies and uniform abbreviations. Additionally, comments regarding inputs from other international guidelines were suggested to be considered. Thus, it would be prudent to see the changes in the protocol template after incorporating the comments received from various stakeholders. Industry bodies and universities expect a more robust protocol template harmonising different clinical study phases and various regulatory agencies from the released M11- technical specification: clinical electronic structured harmonized protocol (CESHARP).
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